Study of GBR 1342, a CD38/CD3 Bispecific Antibody, in Subjects With Previously Treated Multiple Myeloma
Status: | Recruiting |
---|---|
Conditions: | Blood Cancer, Hematology, Hematology |
Therapuetic Areas: | Hematology, Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 12/14/2018 |
Start Date: | October 16, 2017 |
End Date: | April 2020 |
Contact: | Vilia Dragovoy |
Email: | clinicaltrialsdisclosuredesk@glenmarkpharma.com |
Phone: | (201) 684-8000 |
A Phase 1, First-in-Man, Multicenter, Open-Label, Two Part Dose- Escalation and Cohort Expansion Study of Single-Agent GBR 1342 in Subjects With Previously Treated Multiple Myeloma
The purpose of this study is to determine the safety profile and maximum tolerable dose (MTD)
of single-agent GBR 1342 in subjects with multiple myeloma who have received prior therapies.
of single-agent GBR 1342 in subjects with multiple myeloma who have received prior therapies.
Inclusion Criteria:
- Males or females with multiple myeloma who have exhausted available standard
therapies.
- Measurable disease, defined as any quantifiable monoclonal protein value
- ECOG performance-status score of 2 or less
- Life expectancy of at least 3 months
- Recovered from any previous surgery and no history of major surgery within the last 28
days prior to start of study drug
Exclusion Criteria:
- Any condition that, in the opinion of the Investigator, would interfere with
evaluation of the study drug or interpretation of subject safety or study results.
- Active infectious disease considered by the Investigator to be incompatible with the
protocol.
- Evidence of clinically significant cardiovascular and respiratory conditions
- Anti-myeloma treatment within 2 weeks
- Use of any investigational drug within the past 4 weeks
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